On 19 May 2020, USFDA approved twice daily version of Ferriprox (Deferiprone) tablets. This newly approved Ferriprox is a delayed release tablet dosage form requires to be administered two times daily.
The previously approved Ferriprox tablets are immediate release dosage forms and in contrast to the newer version, the Ferriprox immediate release tablets require to be administered three times daily.
Advantage of new version: Reduced administration frequency. As mentioned in Chiesi’s press release (See here), “The new formulation of twice-a-day Ferriprox 1000 mg oral tablets eliminates the mid-day dose.”
Currently, Chiesi is the NDA holder for Ferriprox. Chiesi has acquired this product from Apotex (See here).
Comparison between Ferriprox twice daily and thrice daily versions is available below:
Want to read more on other 505(b)(2) approvals of 2020, then click here.
List of 505(b)(2) approvals of 2019 is available here.
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